Search results for " attribute"
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Ensuring the Quality of Biologicals
has established general monographs that cover common quality attributes and that are applicable to a specific class of biologicals such as monoclonal antibodies (mAbs), rDNA products, or vaccines for …
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USP Publishes Monoclonal Antibody Guidelines
Unlike small-molecule medicines, which have more easily defined quality attributes and are relatively easy to characterize, biologics are large-molecule drugs, typically manufactured using living cell…
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Tackling Analytical Method Development for ADCs
Testing for safety and quality attributes (bioburden, endotoxin, pH, osmolality, excipients, and appearance) are either verified using compendial-based platform methods or developed per product.
A…
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Quality by Design and Extractable and Leachable Testing
QTPP information informs the second element of QbD, the critical quality attributes (CQA).
CQA is defined as a physical, biological, or microbiological property or characteristic that should be …
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Continued Process Verification for Biopharma Manufacturing
In general, the nature and extent of CPV should be aligned with the outcomes of process qualification by focusing attention on aspects of processing that are most important to determining the quality …
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Evaluating Design Margin, Edge of Failure and Process
…y (without failure or high amounts of degradation) can be processed and achieve all critical quality attributes (CQAs) and associated product acceptance criteria. Knowledge of product or process acce…
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Challenges in Analytical Method Development and Validation
…c manufacturing (batch-to-batch) consistency versus those that are patient-specific critical quality attributes. A direct potency test method may not exist, and instead, several surrogate test method…
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Using Software in Process Validation
to ensure that the finished product meets all quality attributes, including specifications.
Documentation and traceability for compliance
Part of the validation process is in the documentati…
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Getting it Right from the Start in the Drug Development Process
Both upstream processing and downstream processing can affect critical quality attributes of the drug molecule under development. These effects can result in process-related impurities, product impuri…
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Modeling the Degradation of mAb Therapeutics
The steeper monomer loss at high temperature is attributed to the increase in the collision frequency due to an increase in protein diffusion.
A similar effect was observed upon increasing the…